Unique ID issued by UMIN | UMIN000001507 |
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Receipt number | R000001819 |
Scientific Title | Randomized controlled trial of the effect of irsogladine maleate on the mucosal injury of small intestine in regular users of loxoprofen sodium |
Date of disclosure of the study information | 2008/11/15 |
Last modified on | 2012/11/19 21:53:11 |
Randomized controlled trial of the effect of irsogladine maleate on the mucosal injury of small intestine in regular users of loxoprofen sodium
Randomized controlled trial of the effect of irsogladine maleate on the small intestinlal lesions in NSAID users
Randomized controlled trial of the effect of irsogladine maleate on the mucosal injury of small intestine in regular users of loxoprofen sodium
Randomized controlled trial of the effect of irsogladine maleate on the small intestinlal lesions in NSAID users
Japan |
mucosal injury of small intestine due to NSAID
Gastroenterology |
Others
NO
To evaluate small intesinal mucosal injury due to NSAID use and to investigate the curing effect of irsogladine maleate on the injury by RCT
Safety,Efficacy
Exploratory
grade, number, and improvement of small intestinal lesions evaluated by capsule endoscopy
Interventional
Parallel
Randomized
Open -but assessor(s) are blinded
No treatment
YES
YES
NO
Central registration
2
Treatment
Medicine |
irsogladine maleate
no treatment control
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) regular users of NSAID who have already used NSAID (e.g. loxoprofen) more than 4 weeks, and continue to use further over 8weeks
2) patients with small intestinal lesions detected by screening capsule endoscopy are entered to RCT for treatment by irsogladine maleate
1) patients taking misoprostol
2) patients taking other NSAIDs, steroid, anti-platelet agents except aspirin, anti-coagulants, or anti-cancer drugs
3) patients with contraindication to capsule endoscopy
4) patients with active bleeding lesions
5) severely ill patients
70
1st name | |
Middle name | |
Last name | Yamaji Yutaka |
The University of Tokyo Hospital
Department of Gastroenterology
7-3-1 Hongo, Bunkyo-ku, Tokyo
1st name | |
Middle name | |
Last name |
The University of Tokyo Hospital
Department of Gastroenterology
03-3815-5411(33070)
Department of Gastroenterology, The University of Tokyo Hospital
Department of Gastroenterology, The University of Tokyo Hospital
Self funding
NO
2008 | Year | 11 | Month | 15 | Day |
Unpublished
Completed
2008 | Year | 08 | Month | 18 | Day |
2008 | Year | 11 | Month | 01 | Day |
2012 | Year | 09 | Month | 30 | Day |
2012 | Year | 09 | Month | 30 | Day |
2012 | Year | 09 | Month | 30 | Day |
2012 | Year | 12 | Month | 31 | Day |
2008 | Year | 11 | Month | 15 | Day |
2012 | Year | 11 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001819
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